Peanut AllergyPhase 1/2NCT03936998
VE416 for Treatment of Food Allergy
A Phase 1/2 study testing Vancomycin plus VE416 before PNOIT and Vancomycin plus VE416 with PNOIT in people with Peanut Allergy, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is a single-center, randomized, double-blind trial with four arms evaluating VE416 as pretreatment or concurrent treatment in comparison to low-dose peanut oral immunotherapy (PNOIT) alone. Read more about this study
- Who is it for?
- Ages 12 to 55 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Vancomycin plus VE416 before PNOIT and Vancomycin plus VE416 with PNOIT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2019to 1 Jan 2024
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- People of all ethnic/racial/gender groups aged 12-55 years old with a documented medical history of peanut allergy.
- Evidence of peanut-specific IgE by either: positive skin prick test to peanut (reaction wheal at least 5 mm larger than saline control) or serum peanut-specific IgE _5 kU/L at screening visit.
- Ara h 2 specific IgE >0.35 kU/L at screening visit.
- Willing to sign informed consent or whose parent or legal guardian is willing to sign the consent form (age appropriate).
- Willing to sign the assent form, if age appropriate.
- (For continuation into Phase II only) Allergic reaction requiring treatment at _ 100 mg dose of peanut protein during Entry Challenge.
Who cannot join
- History of severe anaphylaxis as defined by hypoxia (cyanosis or SpO2 <92% during reaction), documented hypotension (documented systolic BP >30% below predicted normal for sex, height, weight or from known baseline), neurological compromise (confusion, loss of consciousness), or incontinence.
- Severe or Moderate asthma as defined using the severity criteria of the current NHLBI Guidelines for the Diagnosis and Management of Asthma (http://www.nhlbi.nih.gov/guidelines/asthma/).
- Poorly-controlled asthma as defined by FEV1 <80% or any of the following symptoms: nighttime awakening >2 days/week or rescue medication use >2 days / week.
- Diagnosis of other severe or complicating medical problems, including autoimmune or chronic immune inflammatory conditions or gastrointestinal inflammatory conditions, including Celiac Disease, Inflammatory Bowel Disease and Eosinophilic Gastrointestinal Disorders
- Inability to cooperate with and/or perform oral food challenge procedures.
- Inability to swallow size 0 capsule
Show all 13Show fewer
- Primary Immune Deficiency
- Allergy to oat confirmed by skin prick testing and history
- Current use of beta blockers, angiotensin converting enzyme inhibitors, or monoamine oxidase inhibitors
- Women of childbearing potential who are pregnant, planning to become pregnant, or breastfeeding
- Hematocrit <0.36 for adult females or <0.38 for adult males Weight <23 kg
- Use within the past 6 months of other systemic immunomodulatory treatments including allergen immunotherapy, or use of biologics with an immune target, including omalizumab.
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study may also exclude a participant from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Wayne G Shreffler, MD, PhD, 617-643-9089, WSHREFFLER@mgh.harvard.edu
Jannat Gill, MPH, jgill0@mgh.harvard.edu
About this study
Official title: VE416 and Low-dose Peanut Oral Immunotherapy for Treatment of Persistent Peanut Allergy
This is a single-center, randomized, double-blind trial with four arms evaluating VE416 as pretreatment or concurrent treatment in comparison to low-dose peanut oral immunotherapy (PNOIT) alone.
Read the detailed description
In this research study the investigators want to learn more about an investigational medicine called VE416 in combination with vancomycin (an antibiotic) while undergoing peanut oral immunotherapy. VE416 is a combination of dormant (inactive) bacteria given in a capsule. The bacteria are reactivated once they reach participants intestines and in combination with peanut flour may help to prevent participants from getting sick (upset stomach, breathing problems, and skin problems) when participants come into contact with peanuts.
The investigators are doing this research study to find out if VE416 in combination with vancomycin (an antibiotic) while undergoing peanut oral immunotherapy can help people with peanut allergy. VE416 is a consortium of commensal, or "friendly", dormant (inactive) bacteria given in a capsule. The bacteria are reactivated once they reach participants intestines. The investigators also want to find out if VE416 with peanut oral immunotherapy is safe to take without causing too many side effects.
- Conditions
- Peanut Allergy
- Being tested
- Vancomycin plus VE416 before PNOIT, Vancomycin plus VE416 with PNOIT, Placebo plus VE416 with PNOIT, Placebo plus placebo with PNOIT
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin plus VE416 before PNOITCombination product
Vancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks followed by PNOIT
Vancomycin plus VE416 with PNOITCombination product
Placebo for vancomycin for 5 days and placebo for VE416 x 6 weeks, followed by Vancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks with concomitant PNOIT
Placebo plus VE416 with PNOITCombination product
Placebo for vancomycin for 5 days and placebo for VE416 x 6 weeks, followed by placebo for vancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks with concomitant PNOIT
Placebo plus placebo with PNOITCombination product
Placebo for vancomycin for 5 days and placebo for VE416 x 6 weeks, followed by placebo for vancomycin PO QD x 5 days, followed by placebo for VE416 PO QD x 6 weeks with concomitant PNOIT
| Study group | Role | What they receive |
|---|---|---|
| vancomycin plus VE416 before PNOIT | Experimental | active vancomycin plus VE416 before PNOIT Receives: Combination Product: Vancomycin plus VE416 before PNOIT |
| Vancomycin plus VE416 with PNOIT | Experimental | active vancomycin plus active VE416 with active PNOIT Receives: Combination Product: Vancomycin plus VE416 with PNOIT |
| Placebo plus VE416 with PNOIT | Experimental | placebo vancomycin plus active VE416 with active VE416 Receives: Combination Product: Placebo plus VE416 with PNOIT |
| Placebo plus placebo with PNOIT | Active comparator | placebo vancomycin and placebo VE416 with active peanut oral immunotherapy Receives: Combination Product: Placebo plus placebo with PNOIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint- Phase 1b
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 7 weeks
Primary Endpoint- Phase II
The geometric mean of the maximum tolerated dose (MTD) of peanut protein at DBPCFC1
Measured: 23 weeks, with 24 week Post-Phase II maintenance phase followed by a DBPCFC
Secondary outcomes (2)
Secondary Endpoint- Efficacy
The percentage of patients tolerating 600 mg (1030 mg cumulative) at DBPCFC1 without treatment
Measured: 54 weeks
Secondary Endpoint- Safety
The occurrence of treatment related adverse events
Measured: 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start28 Jun 2019
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, randomized, double-blind trial with four arms evaluating VE416 as pretreatment or concurrent treatment in comparison to low-dose peanut oral immunotherapy (PNOIT) alone.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vedanta Biosciences, Inc.
- Responsible party
- Principal investigator, Wayne G. Shreffler, MD, PhD, Massachusetts General Hospital
- Investigators
- Wayne G Shreffler, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936998
- Sponsor's protocol ID
- 2019P000886
- Status last verified
- Oct 2023
- First submitted
- 17 Apr 2019
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Berin MC. Dysbiosis in food allergy and implications for microbial therapeutics. J Clin Invest. 2021 Jan 19;131(2):e144994. doi: 10.1172/JCI144994.
PubMed 33463542
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VE416 and Low-dose Peanut Oral Immunotherapy for Treatment of Persistent Peanut Allergy
- ClinicalTrials.gov ID
- NCT03936998
- Acronym / sponsor ID
- 2019P000886
- Conditions
- Peanut Allergy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Vedanta Biosciences, Inc.
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, randomized, double-blind trial with four arms evaluating VE416 as pretreatment or concurrent treatment in comparison to low-dose peanut oral immunotherapy (PNOIT) alone.
Detailed description
In this research study the investigators want to learn more about an investigational medicine called VE416 in combination with vancomycin (an antibiotic) while undergoing peanut oral immunotherapy. VE416 is a combination of dormant (inactive) bacteria given in a capsule. The bacteria are reactivated once they reach participants intestines and in combination with peanut flour may help to prevent participants from getting sick (upset stomach, breathing problems, and skin problems) when participants come into contact with peanuts.
The investigators are doing this research study to find out if VE416 in combination with vancomycin (an antibiotic) while undergoing peanut oral immunotherapy can help people with peanut allergy. VE416 is a consortium of commensal, or "friendly", dormant (inactive) bacteria given in a capsule. The bacteria are reactivated once they reach participants intestines. The investigators also want to find out if VE416 with peanut oral immunotherapy is safe to take without causing too many side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This is a single-center, randomized, double-blind trial with four arms evaluating VE416 as pretreatment or concurrent treatment in comparison to low-dose peanut oral immunotherapy (PNOIT) alone.
| Arm | Type | Receives |
|---|---|---|
| vancomycin plus VE416 before PNOIT | Experimental | Combination Product: Vancomycin plus VE416 before PNOITactive vancomycin plus VE416 before PNOIT |
| Vancomycin plus VE416 with PNOIT | Experimental | Combination Product: Vancomycin plus VE416 with PNOITactive vancomycin plus active VE416 with active PNOIT |
| Placebo plus VE416 with PNOIT | Experimental | Combination Product: Placebo plus VE416 with PNOITplacebo vancomycin plus active VE416 with active VE416 |
| Placebo plus placebo with PNOIT | Active comparator | Combination Product: Placebo plus placebo with PNOITplacebo vancomycin and placebo VE416 with active peanut oral immunotherapy |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- People of all ethnic/racial/gender groups aged 12-55 years old with a documented medical history of peanut allergy.
- Evidence of peanut-specific IgE by either: positive skin prick test to peanut (reaction wheal at least 5 mm larger than saline control) or serum peanut-specific IgE _5 kU/L at screening visit.
- Ara h 2 specific IgE >0.35 kU/L at screening visit.
- Willing to sign informed consent or whose parent or legal guardian is willing to sign the consent form (age appropriate).
- Willing to sign the assent form, if age appropriate.
Key exclusion criteria (13 listed)
- History of severe anaphylaxis as defined by hypoxia (cyanosis or SpO2 <92% during reaction), documented hypotension (documented systolic BP >30% below predicted normal for sex, height, weight or from known baseline), neurological compromise (confusion, loss of consciousness), or incontinence.
- Severe or Moderate asthma as defined using the severity criteria of the current NHLBI Guidelines for the Diagnosis and Management of Asthma (http://www.nhlbi.nih.gov/guidelines/asthma/).
- Poorly-controlled asthma as defined by FEV1 <80% or any of the following symptoms: nighttime awakening >2 days/week or rescue medication use >2 days / week.
- Diagnosis of other severe or complicating medical problems, including autoimmune or chronic immune inflammatory conditions or gastrointestinal inflammatory conditions, including Celiac Disease, Inflammatory Bowel Disease and Eosinophilic Gastrointestinal Disorders
- Inability to cooperate with and/or perform oral food challenge procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vancomycin plus VE416 before PNOITVancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks followed by PNOIT | Combination product | vancomycin plus VE416 before PNOIT |
| Vancomycin plus VE416 with PNOITPlacebo for vancomycin for 5 days and placebo for VE416 x 6 weeks, followed by Vancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks with concomitant PNOIT | Combination product | Vancomycin plus VE416 with PNOIT |
| Placebo plus VE416 with PNOITPlacebo for vancomycin for 5 days and placebo for VE416 x 6 weeks, followed by placebo for vancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks with concomitant PNOIT | Combination product | Placebo plus VE416 with PNOIT |
| Placebo plus placebo with PNOITPlacebo for vancomycin for 5 days and placebo for VE416 x 6 weeks, followed by placebo for vancomycin PO QD x 5 days, followed by placebo for VE416 PO QD x 6 weeks with concomitant PNOIT | Combination product | Placebo plus placebo with PNOIT |
Primary outcome
Primary Endpoint- Phase 1b
Time frame: 7 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Primary Endpoint- Phase II
Time frame: 23 weeks, with 24 week Post-Phase II maintenance phase followed by a DBPCFC
The geometric mean of the maximum tolerated dose (MTD) of peanut protein at DBPCFC1
2 secondary outcomes
Secondary Endpoint- Efficacy
Time frame: 54 weeks
Secondary Endpoint- Safety
Time frame: 54 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Derived from this study: PubMed 33463542Berin MC. Dysbiosis in food allergy and implications for microbial therapeutics. J Clin Invest. 2021 Jan 19;131(2):e144994. doi: 10.1172/JCI144994.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wayne G Shreffler, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vancomycin plus VE416 before PNOIT and Vancomycin plus VE416 with PNOIT in people with Peanut Allergy, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wayne G Shreffler, MD, PhD (617-726-6147, wshreffler@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint- Phase 1b (time frame: 7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03936998, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.